GLYBURIDE- glyburide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)

Available from:

REMEDYREPACK INC.

INN (International Name):

GLYBURIDE

Composition:

GLYBURIDE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glyburide tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide tablets are contraindicated in patients with: - Known hypersensitivity or allergy to the drug. - Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. - Type I diabetes mellitus. - Concomitant administration of bosentan.

Product summary:

Glyburide tablets USP, 1.25 mg are white, round, and functionally scored tablets engraved with BP 606 on one side and 1.25 on the other side. They are supplied as follows: NDC 52817-120-10 bottles of 100 Glyburide tablets USP, 2.5 mg are peach-colored, round, and functionally scored tablets engraved with BP 607 on one side and 2.5 on the other side. They are supplied as follows: NDC 52817-121-10 bottles of 100 Glyburide tablets USP, 5 mg are green-colored, round, and functionally scored tablets engraved with BP 608 on one side and 5 on the other side. They are supplied as follows: NDC 52817-122-10 bottles of 100 NDC 52817-122-00 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container. Keep container tightly closed. Distributed by: TruPharma, LLC Tampa, FL 33609 Manufactured by: Pharmadax Inc. Guangdong Province, P.R. China 528244 Rev. 07/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLYBURIDE- GLYBURIDE TABLET
REMEDYREPACK INC.
----------
DESCRIPTION
Glyburide tablets USP contain glyburide, which is an oral
blood-glucose-lowering drug of the
sulfonylurea class. Glyburide is a white, crystalline compound. The
chemical name for glyburide is 1-
[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]-sulfonyl]-3-cyclohexylurea
and the molecular weight is
493.99. It has the following structural formula:
Molecular formula: C
H
ClN
O
S
Each tablet, for oral administration, contains 1.25 mg, 2.5 mg or 5 mg
of glyburide. In addition, each
tablet contains the following inactive ingredients: lactose
monohydrate, magnesium stearate, sodium
starch glycolate, and talc. In addition, the 2.5 MG contains red iron
oxide and yellow iron oxide; the 5
MG contains D&C yellow No. 10 aluminum lake and FD&C blue No.
1/brilliant blue FCF aluminum lake.
CLINICAL PHARMACOLOGY
ACTIONS
Glyburide appears to lower the blood glucose acutely by stimulating
the release of insulin from the
pancreas, an effect dependent upon functioning beta cells in the
pancreatic islets. The mechanism by
which glyburide lowers blood glucose during long-term administration
has not been clearly
established. With chronic administration in Type II diabetic patients,
the blood glucose lowering effect
persists despite a gradual decline in the insulin secretory response
to the drug. Extrapancreatic effects
may be involved in the mechanism of action of oral sulfonylurea
hypoglycemic drugs. The combination
of glyburide and metformin may have a synergistic effect, since both
agents act to improve glucose
tolerance by different but complementary mechanisms.
Some patients who are initially responsive to oral hypoglycemic drugs,
including glyburide, may
become unresponsive or poorly responsive over time. Alternatively,
glyburide tablets may be effective
in some patients who have become unresponsive to one or more other
sulfonylurea drugs.
In addition to its blood glucose lowering actions, glyburide produces
a mild diuresis by enhancement of
renal free water clearance.